AssayIndex

AX-2026-041705

Hexarelin · 10 mg declared · Qingdao Sigma Chemical Co., Ltd. · lot QSC-2601-N9656

FAILPURITY ONLY
Report ID
AX-2026-041705
Compound
Hexarelin
Compound class
Growth-hormone axis peptides
Supplier
QSC — Qingdao Sigma Chemical Co., Ltd.
Batch / lot
QSC-2601-N9656
Declared label claim
10mg
Laboratory
PeptideMeter
Assay date
21 Apr 2026
Submitted
17 May 2026
Quarter
2026-Q2
Submitter
ad.marchand
Sample provenance
Supplier-supplied
Section 1

Results

Measured against the index acceptance specification for the growth-hormone axis peptides class. A specification is a decision the index made; a result is a measurement. See where each threshold came from.

ParameterMethodResultUnitIndex spec
PurityRP-HPLC, 28 min gradient, 214 nm99.60% area≥ 99.0PASS
Total impuritiesRP-HPLC, sum of reported peaks0.40% area≤ 1.0PASS
Largest single impurityRP-HPLC — oxidised Trp (+16 Da)0.21% area≤ 1.00PASS
Identitynot ordered on this submissionnot determinedrequired for VERIFIED statusNOT TESTED
Total peptide contentby difference from the gravimetric mass balance87.28%w/wNOT TESTED
Target-compound contenttotal peptide content × purity86.93%w/wNOT TESTED
Gross fill (as weighed)five-place balance, under nitrogen12.36mg10 mg declaredNOT TESTED
Recovered target peptidegross fill × target content10.745mg10 mg claimNOT TESTED
Recovery against label claimrecovered ÷ claim107.5%90.0 – 110.0PASS
Water contentKarl Fischer, coulometric, duplicate6.12%≤ 9.0PASS
Counter-ion (acetate)anion-exchange ion chromatography6.28%≤ 12.0PASS
Residual solvent + inorganic residueestimated — see /methods/residual-solvents-q3c/0.32%NOT TESTED
Endotoxinkinetic chromogenic LAL7.28EU/mg≤ 5.0FAIL
Sterilitymembrane filtration, USP <71>, 14 dNo growth at 14 dno growthPASS
Appearancevisual, diffuse light, black and white backgroundWhite powder, no defined cake (melt-back)white to off-white intact cakeFAIL
Reconstitution clarityreconstituted per submitter procedureClear, colourless, no visible particulatesclear, no visible particulatesPASS
pH (reconstituted, 1 mg/mL)potentiometric, two-point calibration4.762.5 – 8.0PASS
Retention time (observed)RP-HPLC, 28 min gradient8.44min8.37 ± 0.25 (normalised)PASS
Peak asymmetry (10 % height)Ph. Eur. 2.2.461.010.80 – 1.50PASS
Plate count, main peakN = 5.54 (t/w½)²86,812≥ 20,000PASS
Resolution to nearest impurityvs C-terminal free acid (+1 Da)1.27no index criterionREPORTED
Section 2

Chromatogram and peak integration

The figure is drawn from the table. It is not an independent illustration — if a number in the table changed, the trace would change with it.

0400580101201516019 Hexarelin8.44 min · 99.60 % 8.12 same trace · ×200 vertical expansion, baseline-corrected · main peak off-scale reporting threshold 0.05 % area 051015202530 Retention time (min) Response (mAU)
Figure 1. RP-HPLC trace, 28 min gradient, 214 nm. Drawn from the peak-integration table below: peak positions are the reported retention times, peak areas are the reported area percentages, peak widths follow the reported plate count of 86,812, and skew follows the reported asymmetry factor of 1.01. Baseline noise is seeded from the report ID and is illustrative. The lower panel is the same trace at a stated vertical expansion with the slow gradient drift subtracted, because at full scale a 0.21 % impurity against a 99.60 % main peak is a line two pixels tall; the main peak runs off-scale there by design.
#PeakRTArea (µV·s)% areaΔ mass (Da)
1Hexarelin — main peak8.444,840,86999.60
2oxidised Trp (+16 Da)8.1210,2070.21+15.995
3des-methyl hexarelin (GHRP-6, −14 Da)7.996,3180.13-14.016
4C-terminal free acid (+1 Da)8.591,4580.03+0.984
5des-Lys (−128 Da)8.231,4580.03-128.095
Closure check — purity + Σ impurities 100.00CLOSES

Reporting threshold 0.05 % area. Peaks below it are not reported and are therefore excluded from the total, which overstates purity by their sum — see peak integration.

Section 4

Gravimetric mass balance

Water, counter-ion, residual and total peptide content are exhaustive and mutually exclusive categories. They must account for 100 % of the cake mass. The index closes this to within 0.02 pp and the build asserts it.

ComponentDetermination%w/w of cake
WaterKarl Fischer6.12
Counter-ion (acetate)ion chromatography6.28
Residual solvent + inorganic residueestimated0.32
Total peptide contentby difference87.28
Total100.00 CLOSES

Supplier certificate, as declared

The supplier's own figures for this lot, beside the independent measurement. Divergence is assessed against the batch median, not against this single report — see rule AX-R05.

FigureSupplier COAThis reportIndex note
Purity (% area)99.9099.60divergence +0.16 pp vs batch median
Total impurities (% area)0.100.40
Largest single impurity (% area)not stated0.21
Water (%)not stated6.12
Counter-ion (%)6.26.28
Peptide content (%w/w)89.787.28
Endotoxin (EU/mg)not stated7.28
Method stated on certificateYEScolumn, gradient and wavelength given
Section 5

Provenance and caveats

Where a sample came from changes the weight of the evidence. The index treats it as a first-class field.

Sample provenance
Supplier-supplied
Evidentiary weight
Weaker evidence. Read with the caveat below.
Chain of custody
Supplier despatch → laboratory direct (courier, cold pack, 5 d) → assay. Submitter did not handle the vial.
Assay date
21 Apr 2026
Submitted to the index
17 May 2026
Laboratory
PeptideMeter, Tallinn, Estonia
Method basis
28 min gradient · high-resolution MS
Verification status
PURITY ONLY
Section 6

Annotations 4

Signed technical comments from index contributors. Not a discussion forum — annotations question or contextualise the result, and the data team replies where a reply is warranted.

lal_assay
7.28 EU/mg is above the index screening threshold of 5.0. Two things to keep separate: the index threshold is a screening figure, and a real limit is dose-dependent. The endotoxin dose-limit calculator does that arithmetic. What this record establishes is that the burden is measurable and high relative to the rest of the dataset.
lot_traceability
No endotoxin figure on this record, which is true of roughly three quarters of the index. It is the one measurement that cannot be inferred from any other and the one most often omitted.
ftir_amide_i
High endotoxin 7.28 EU/mg on high-purity material vs purity suggests water quality at the fill step. If the lot was lyophilised from non-purified water, this is the expected finding.
underfill_3to1
7.28 EU/mg from an older lot. Endotoxins are heat-stable and drift is rare. If this matches fresh-lot median from the same supplier, the number is stable.
Section 7

Related records

Same batch — lot QSC-2601-N9656 n=7

ReportLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041703QSC-2601-N9656Medutest2026-Q299.775.65103.3Supplier-supplied0PASS
AX-2026-041704QSC-2601-N9656Medutest2026-Q299.746.27Supplier-supplied1MARGINAL
AX-2026-041706QSC-2601-N9656PeptideMeter2026-Q299.575.88Supplier-supplied1MARGINAL
AX-2026-041707QSC-2601-N9656Janoshik2026-Q299.745.68104.8Supplier-supplied1FAIL
AX-2026-041708QSC-2601-N9656VendorInvestigate2026-Q299.575.9290.4Buyer-sourced2FAIL
AX-2026-041709QSC-2601-N9656Janoshik2026-Q299.845.39Supplier-supplied1MARGINAL
Other recent Hexarelin records in the index.
ReportSupplierLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041892JEEPJEEP-2608-Y4367Janoshik2026-Q399.553.6198.9Supplier-supplied1MARGINAL
AX-2026-041893JEEPJEEP-2608-Y4367PeptideMeter2026-Q399.443.58103.2Supplier-supplied0PASS
AX-2026-043049KPKP-2604-X5435Nordanalyt2026-Q298.463.64103.0Buyer-sourced2FAIL
AX-2026-043279CPCCPC-2511-F1491PeptideMeter2026-Q298.875.35Supplier-supplied2FAIL
AX-2026-042137HomopeptideHOMO-2602-R8195Janoshik2026-Q299.933.9490.6Supplier-supplied1MARGINAL
AX-2026-043048KPKP-2604-X5435VendorInvestigate2026-Q298.283.1594.2Buyer-sourced2FAIL
AX-2026-043274CPCCPC-2511-F1491PeptideMeter2026-Q298.895.10Supplier-supplied2FAIL
AX-2026-043046KPKP-2604-X5435Nordanalyt2026-Q299.003.50Supplier-supplied2MARGINAL
Other recent QSC records in the index.
ReportCompoundLotLabQuarterPurity %Water %Recovery %ProvenanceFlagsResult
AX-2026-041683CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.933.6397.1Supplier-supplied1FAIL
AX-2026-041727CJC-1295 with DACQSC-2602-E9474Janoshik2026-Q398.886.62105.3Supplier-supplied1MARGINAL
AX-2026-041728CJC-1295 with DACQSC-2602-E9474VendorInvestigate2026-Q398.427.04Buyer-sourced1MARGINAL
AX-2026-041734CJC-1295 with DACQSC-2602-E9474Medutest2026-Q399.437.17105.5Supplier-supplied2FAIL
AX-2026-041652LiraglutideQSC-2605-W8602Nordanalyt2026-Q399.336.55Supplier-supplied0PASS
AX-2026-041730CJC-1295 with DACQSC-2602-E9474PeptideMeter2026-Q398.796.9395.4Supplier-supplied1MARGINAL
AX-2026-041686CJC-1295 (no DAC)QSC-2606-V8637Janoshik2026-Q399.934.04Supplier-supplied0PASS
AX-2026-041653LiraglutideQSC-2605-W8602VendorInvestigate2026-Q398.825.95Buyer-sourced0PASS